CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Talzenna (talazoparib) — Coverage Criteria

Defines accepted indications, continuation rules, exclusions, and authorization structure for talazoparib (Talzenna) requests processed by the UM department; applies to medication requests reviewed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTalzenna (talazoparib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative review — no material coverage changes

Effective DateNovember 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization to Evolent/UM with required documentation (FDA label, CMS compendia, NCCN/ASCO guidance or peer‑reviewed evidence) and evidence of HER2-negative and germline BRCA1/2 status as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11/13/24most recent approval date

11/29/24effective date

2indications

1 mgsingle dose max

listedcapsule limits

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Coverage Criteria for Talzenna (talazoparib)

Breast Cancer (Initial/Monotherapy)

Covered when ALL of the following are met

Breast cancer indication: Talazoparib may be used as monotherapy for members with HER2-negative and germline BRCA1/2 mutated locally advanced or metastatic breast cancer.

References include EMBRACA trial and FDA label

Prostate Cancer (mCRPC with HRR mutations, excluding BRCA1/2)

Covered when ALL of the following are met

Prostate cancer indication: Talazoparib may be used with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) excluding cases with BRCA1 or BRCA2 mutations. Allowed HRR gene alterations include ATM, ATR, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCA, FANCL, MLH1, MREL11A, NBN, PALB2, RAD51B, RAD51C, RAD51D, and RAF54L.

Patients should receive concurrent GnRH analog or have had bilateral orchiectomy.

Requests will be denied if there is documented disease progression while taking talazoparib or another PARP inhibitor. Coverage is also excluded for members with BRCA1/2-positive metastatic castration-resistant prostate cancer (mCRPC). Prior to initiation, the provider must document the member’s HER2-negative status and germline BRCA1/2 mutation; lack of this documentation is an exclusion. Concurrent administration with other anticancer therapies is not allowed. Dosing that exceeds the policy limits — a single dose of 1 mg or the specified monthly capsule maximums — will be denied.

Uses that are investigational or off-label and are not supported by authoritative sources will be considered not medically necessary. The policy requires supporting evidence from FDA labeling, CMS-recognized compendia, or acceptable peer-reviewed literature. Evidence that is insufficient includes case reports, abstracts without full articles, or studies that do not adequately represent the patient population, treatment regimen, or clinically meaningful outcomes (for example, outcomes that do not meet ASCO-recommended thresholds such as a hazard ratio < 0.80 or at least a 3-month survival benefit). Non-randomized trials may provide supportive evidence in some circumstances, but uncontrolled anecdotal reports and meeting abstracts without full peer-reviewed publication generally do not meet the standard for coverage.

Initial Therapy Criteria

Initial therapy

Initial coverage positions

Initial use: Talazoparib may be initiated as monotherapy for HER2-negative, germline BRCA1/2 mutated locally advanced or metastatic breast cancer, or may be used in combination with enzalutamide for HRR gene–mutated mCRPC excluding BRCA1/2-mutated cases.

Positioning reflects available evidence and alternative regimens for mCRPC.

Continuation Therapy Criteria

Continuation therapy

Continuation requests exemption

Continuation exemption: Continuation requests are exempt if the medication was used within the last year, the member has not experienced disease progression or intolerance to the requested medication, and no additional medication(s) are being added to the continuation request.

Applies to continuation requests for previously used, not-approvable medications per policy.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization and Continuation Rules

Prior authorization and continuation requests for Talzenna (talazoparib) are processed by Evolent/UM. Providers must obtain authorization before dispensing unless the request meets the continuation exemption. Continuation requests are exempt from prior authorization when ALL of the following are met: the medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request.

Evolent/UM processes all medication requests from network ordering providers.
Continuation exemption requires: used within last year; no disease progression or intolerance; no additional medications added.

Note

Prostate Cancer — Preferred Alternatives and Allowed Combinations

For metastatic castration-resistant prostate cancer (mCRPC), talazoparib may be used in combination with enzalutamide only for HRR gene–mutated disease excluding BRCA1 and BRCA2 mutation–positive mCRPC. The policy recognizes preferred alternatives with stronger evidence and recommends those regimens in this disease setting.

Coding and Dose Limits

Single dose limit

Single dose maximum1 mg per single dose

Source noteListed as an exclusion if dosing exceeds single dose limit of 1 mg

Unitmg (milligram)

Monthly capsule limits

0.1 mg capsulesMaximum 30 capsules per month

0.25 mg capsulesMaximum 60 capsules per month

0.35 mg capsulesMaximum 30 capsules per month

Quantity Limits for Talazoparib

Talazoparib (capsules) — monthly limits

0.1 mg30 capsules per month

0.25 mg60 capsules per month

0.35 mg30 capsules per month

0.5 mg30 capsules per month

0.75 mg30 capsules per month

1 mg30 capsules per month

Talazoparib (single dose) — single dose maximum

Key Definitions

mCRPC — definition

DefinitionMetastatic castration-resistant prostate cancer (mCRPC): prostate cancer that has progressed despite castrate levels of testosterone and has evidence of metastatic disease

Treatment contextPolicy permits talazoparib with enzalutamide for HRR gene-mutated mCRPC excluding BRCA1/2-mutated cases

Concurrent requirementPatients should receive a GnRH analog concurrently or have had bilateral orchiectomy

HRR gene-mutated — definition and example genes

DefinitionHRR gene-mutated: presence of deleterious alterations in homologous recombination repair genes

Example genes includedATM, ATR, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCA, FANCL, MLH1, MREL11A, NBN, PALB2, RAD51B, RAD51C, RAD51D, RAF54L

Step Therapy and Preferred Alternatives

Alternative regimen	Evidence positioning / notes
Niraparib + abiraterone acetate with prednisone
Listed as an alternative with stronger supporting evidence; talazoparib + enzalutamide lacks Level 1 evidence versus these regimens
Akeega (niraparib + abiraterone acetate) with prednisone
Identified as an alternative regimen supported in this disease setting; positions talazoparib + enzalutamide as less-preferred
Olaparib + abiraterone acetate with prednisone
Included among recommended alternatives; cited to explain why talazoparib + enzalutamide is used despite lacking Level 1 evidence

Background

Talazoparib (Talzenna) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated in this policy for two scenarios: as monotherapy for members with HER2-negative, germline BRCA1/2-mutated locally advanced or metastatic breast cancer, and in combination with enzalutamide for HRR gene–mutated metastatic castration-resistant prostate cancer (mCRPC) when BRCA1/2 mutations are excluded and concurrent androgen-deprivation therapy is in place. The policy bases coverage decisions on the drug’s FDA-approved labeling, clinical trial evidence (for example, EMBRACA in breast cancer), and recognized guidance such as NCCN/ASCO recommendations and CMS compendia, with peer‑reviewed literature used to support off-label considerations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTalzenna (talazoparib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative review — no material coverage changes

Effective DateNovember 29, 2024

Next Review DateN/A

SourceLink

On This Page

Talazoparib + enzalutamide allowed for mCRPC positive for ATM, ATR, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCA, FANCL, MLH1, MREL11A, NBN, PALB2, RAD51B, RAD51C, RAD51D, or RAF54L (BRCA1/2 excluded).
Preferred alternative regimens: niraparib + abiraterone acetate with prednisone; Akeega (niraparib + abiraterone acetate) with prednisone; olaparib + abiraterone acetate with prednisone.
Patients on talazoparib + enzalutamide should concurrently receive a GnRH analog or have had bilateral orchiectomy.

Documentation Required

Required Supporting Documentation

Requests must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Documentation should include genetic testing results for HRR genes and BRCA1/2 status where applicable, relevant prior treatment history, evidence of clinical benefit or lack of progression for continuation requests, and prescribed dosing that does not exceed single-dose or monthly capsule limits.

Acceptable evidence: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or qualifying peer‑reviewed literature per CMS Chapter 15.
Required documentation: HRR gene test results including BRCA1/2; prior PARP inhibitor exposure and response; prior and concurrent anticancer therapies; dosing and quantity justification (single dose limit 1 mg; monthly capsule limits as specified).
For continuation requests: documentation that member has not experienced disease progression or intolerance and that medication was used within the last year.

Denial Risk

Common Denial Triggers and Exclusions

Common denial triggers include disease progression while on talazoparib or another PARP inhibitor, BRCA1/2 positive mCRPC when talazoparib is being requested for combination use in prostate cancer, concurrent use with other anticancer therapies, dosing or quantity limits exceeded, and insufficient supporting documentation per the evidence standards.

Denial triggers: progression on a PARP inhibitor (e.g., olaparib); BRCA1/2 positive mCRPC for talazoparib + enzalutamide; lack of documentation of HER2-negative and BRCA1/2 germline testing prior to initiation; concurrent anticancer therapies without justification; dosing >1 mg single dose or monthly capsule limits exceeded.
Investigational/off‑label indications lacking CMS compendia or acceptable peer‑reviewed evidence will be denied.

0.5 mg capsulesMaximum 30 capsules per month

0.75 mg capsulesMaximum 30 capsules per month

1 mg capsulesMaximum 30 capsules per month

Single dose maximum1 mg per single dose

ExclusionRequests exceeding the single dose limit of 1 mg are listed as an exclusion criterion

Coverage noteTalazoparib with enzalutamide is permitted for mCRPC positive for any one of the listed HRR genes, excluding BRCA1/2